Method and Apparatus for Delivering a Therapeutic Substance Through an Injection Port

ABSTRACT

Adapters for utilizing a syringe or pen injector with a subcutaneous injection port to deliver a therapeutic substance through the injection port and methods of using the adapters are provided. A syringe adapter has a body having a first end and a second end. The first end of the body is configured to receive and engage the end of a syringe so that the cannula of the syringe is held at a fixed position with the respect to the adapter. The second end of the adapter configured to mate with a mating portion of the injection port. When the second end of the adapter engages the mating portion of the injection port, the adapter assures that the cannula of the syringe is properly aligned with the subcutaneous injection port and assures that the cannula penetrates the injection port to the proper depth. Adapters for use with pen style delivery systems are also disclosed. Additionally, an adapter to facilitate loading a syringe with a therapeutic substance from a vial is disclosed.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.12/923,649, filed on Sep. 30, 2010, which is a division of U.S. patentapplication Ser. No. 11/948,804, filed on Nov. 30, 2007, which claimsthe benefit under 35 U.S.C. §119(e) of provisional application Ser. No.60/873,580, filed on Dec. 8, 2006, the entire disclosures of each ofsaid prior applications being incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to the delivery of therapeutic substancesthrough injection ports. More particularly, the present inventionrelates to a method and apparatus for using a syringe or pen injector todeliver a therapeutic substance through a subcutaneous injection port.

BACKGROUND

Therapeutic substances are often delivered by subcutaneous injection.One common device used to facilitate the delivery of such substances isa subcutaneous injection port. Subcutaneous injection ports typicallyinclude a housing with a soft tubular cannula and an apparatus fordelivering a therapeutic substance to the cannula. To use such a port, apuncturing device such as a rigid needle is used to place the softcannula in the subcutaneous tissue. The rigid needle is then withdrawnand the cannula and housing are left at the infusion site. A therapeuticsubstance may then be introduced through the cannula. This type ofsubcutaneous injection port may be left in a patient for several days.Examples of subcutaneous injection ports are disclosed in U.S. Pat. Nos.6,074,371 to Fischell, and. 6,017,328 to Fischell, which are herebyincorporated by reference in their entirety.

A subcutaneous injection port may be used to deliver a bolus of medicinewith a syringe. A subcutaneous injection port suitable for use with asyringe is disclosed in U.S. Patent Publication No. 2004/0006316 A1 toPatton, which is hereby incorporated by reference in its entirety.

One problem that may occur when injecting therapeutic substances into asubcutaneous injection port with a syringe is misalignment between thecannula of the syringe and the injection port. If there is too muchmisalignment, the injection port may be damaged or improper dosages maybe delivered. Furthermore, a user may completely miss the injectionport, and accidentally stick themselves with the cannula.

Accordingly, there is a need for an improved apparatus for deliveringtherapeutic substances into a subcutaneous injection port.

SUMMARY OF THE INVENTION

An aspect of the present invention is to address at least the aboveproblems and/or disadvantages and to provide at least the advantagesdescribed below. Accordingly, an aspect of the present invention is toprovide an adapter for aligning a cannula of a syringe or pen injectionwith an injection port, such as a subcutaneous injection port.

Another aspect of the present invention is to provide an adapter forcontrolling the depth of penetration of a cannula of a syringe or peninjection needle into an injection port, such as a subcutaneousinjection port.

Yet another aspect of the present invention is to provide an adapterthat shields a cannula of a syringe or pen needle to prevent accidentalneedle punctures.

In accordance with an aspect of the present invention, an adapter forutilizing a syringe with an injection port, such as a subcutaneousinjection port, is provided. The adapter has a body having a first endand a second end. The first end of the body is adapted to receive an endof a syringe. The second end of the adapter is adapted to mate with theinjection port. The adapter aligns the cannula of the syringe with theinjection port and controls the depth of penetration of the cannula.

In accordance with another aspect of the present invention, an adapterfor utilizing a pen delivery system with an injection port, such as asubcutaneous injection port, comprises an outer shield and a pen needledisposed in the outer shield. The outer shield has a first end and asecond end. The first end of the outer shield is configured to mate witha pen delivery system.

The second end of the outer shield is configured to mate with aninjection port. The adapter aligns the pen needle with the injectionport and controls the depth of penetration of the pen needle.

In accordance with another aspect of the present invention, an adapterfor utilizing a pen delivery system with an injection port, such as asubcutaneous injection port, comprises first, second, and third legsthat are connected together to form a triangular shaped body, first andsecond recesses formed in the first and second legs of the adapter toaccommodate a pen needle assembly, and extending struts on the first andsecond legs that are arranged in a geometric pattern that corresponds tothe shape of corresponding features on an injection port. The adapteraligns the pen needle with the injection port and controls the depth ofpenetration of the pen needle.

In accordance with another aspect of the present invention, a vialadapter for use with an injection port adapter comprises a disc with abottom surface and a top surface. A plurality of flexible fingers extendfrom the bottom surface of the disc and have a retention flange formedon an inner surface of the fingers. The flexible fingers are configuredto fit over the neck of vial, and the flexible fingers allow theretention flange to pass over a crimp ring on the neck of a vial. Acylinder extends from the top surface of the disc. The cylinder has anoutside diameter that corresponds to the inner diameter of an injectionport adapter. A septum covers an opening at the top of the cylinder toform a cavity within the cylinder. A cannula extends through the discinto the cavity in the cylinder.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other objects, features, and advantages of certainexemplary embodiments of the present invention will be more apparentfrom the following description taken in conjunction with theaccompanying drawings, in which:

FIGS. 1A-1G are illustrations of an exemplary embodiment of an injectionport and a method of using the same;

FIG. 2 is a perspective view of a syringe and an injection port adapteraccording to an exemplary embodiment of the present invention;

FIG. 3 is an enlarged perspective of the syringe and injection portadapter of FIG. 2, with the tip of the syringe approaching a centeringring of the adapter;

FIG. 4 is an enlarged perspective of the syringe and injection portadapter of FIG. 2, with the tip of the syringe entering the centeringring of the adapter;

FIG. 5 is a sectional view of the syringe and the injection port adapterof FIG. 2, with the tip of the syringe in the centering ring of theadapter;

FIG. 6 is a perspective view of a syringe suitable for use with theexemplary embodiments of the present invention;

FIG. 7 is a sectional view of the second end of the syringe andinjection port adapter of FIG. 2 mated with an injection port;

FIG. 8 is a perspective view of a syringe and an injection port adapteraccording to another exemplary embodiment of the present invention;

FIG. 9 is a perspective view of the syringe and the injection portadapter of FIG. 8, with the sterility cap of the syringe removed;

FIG. 10 is a perspective view of the syringe and the injection portadapter of FIG. 8, with the adapter in an open position on the end ofthe syringe;

FIG. 11 is a perspective view of the syringe and the injection portadapter of FIG. 8, with the adapter in a closed position on the end ofthe syringe;

FIG. 12 is a front view of a syringe and an injection port adapteraccording to another exemplary embodiment of the present invention;

FIG. 13 is a perspective view of the syringe and the injection portadapter of FIG. 12, with the sterility cap removed;

FIG. 14 is a perspective view of the syringe and the injection portadapter of FIG. 12, approaching an injection port;

FIG. 15 is a sectional view of the end of the syringe and the injectionport adapter of FIG. 12 in place on an injection port

FIG. 16 is an injection port adapter for a syringe according to anotherexemplary embodiment of the present invention;

FIG. 17 is a perspective view of the injection port adapter of FIG. 16and a syringe and an injection port;

FIG. 18 is a perspective view of the injection port adapter of FIG. 16partially installed on a syringe;

FIG. 19 is a perspective view of the injection port adapter of FIG. 16installed on a syringe;

FIG. 20 is a perspective view of the injection port adapter of FIG. 16installed on a syringe and placed on an injection port;

FIG. 21 is a sectional view of the end of the syringe and the injectionport adapter of FIG. 16 in place on an injection port;

FIG. 22 is a front view of a syringe and an injection port adapteraccording to another exemplary embodiment of the present invention;

FIG. 23 is a perspective view of the syringe and injection port adapterof FIG. 22;

FIG. 24 is a front view of the syringe and injection port adapter ofFIG. 22, with the injection port adapter placed on the end of thesyringe;

FIG. 25 is an enlarged schematic view of the syringe and injection portadapter of FIG. 22;

FIG. 26 is an enlarged perspective view of the interior of the injectionport adapter of FIG. 22;

FIG. 27 is a front view of an injection port adapter for use with a penstyle injection device according to another exemplary embodiment of thepresent invention;

FIG. 28 is an enlarged sectional view of a portion of the injection portadapter of FIG. 27;

FIG. 29 a front view of an injection port adapter of FIG. 27, with thesterility cap removed;

FIG. 30 is a schematic view of the injection port adapter of FIG. 27,approaching an injection port;

FIG. 31 is a section view of the injection port adapter of FIG. 27;

FIG. 32 is a perspective view of another embodiment of an injection portadapter for use with a pen style injection device;

FIG. 33 is a perspective view of the injection port adapter of FIG. 32,with the sterility cap removed;

FIG. 34 is a sectional view of the injection port adapter of FIG. 32;

FIG. 35 is a front view of another embodiment of an injection portadapter for use with a pen style injection device, with the injectionport adapter in a flattened state;

FIG. 36 is a top perspective view of the injection port adapter of FIG.35, in a folded state, assembled with a pen style injection device;

FIG. 37 is a bottom perspective view of the injection port adapter ofFIG. 35, in a folded state, assembled with a pen style injection device;

FIG. 38 is a front view of a vial adapter for using an syringe and aninjection port adapter with a vial;

FIG. 39 is a sectional view of the vial adapter of FIG. 38;

FIG. 40 is a front view of the vial adapter of FIG. 38 in the process ofbeing placed on a vial;

FIG. 41 is a front view of the vial adapter of FIG. 38 in place on avial; and

FIG. 42 is a perspective view of the vial adapter of FIG. 38 in theprocess of being used to load medicine in the syringe from the vial.

Throughout the drawings, the same reference numerals will be understoodto refer to the same elements, features, and structures.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

The matters defined in the description such as a detailed constructionand elements are provided to assist in a comprehensive understanding ofthe embodiments of the invention and are merely exemplary. Accordingly,those of ordinary skill in the art will recognize that various changesto and modifications of the embodiments described herein can be madewithout departing from the scope and spirit of the invention. Also,descriptions of well-known functions and constructions are omitted forclarity and conciseness.

Referring to FIGS. 1A-1G, a subcutaneous injection port 10 according toan exemplary embodiment of the present invention includes a body portion12, a soft cannula (or catheter) 14, and a septum 16 that forms a hollowcavity connected to the cannula. To use the injection port, an adhesivematerial is placed on the lower surface of the body portion 12 of theinjection port 10. The adhesive material may be adhesive tape, and thetape may be covered with a liner prior to use to prevent the tape fromadhering to an unwanted surface. After the skin 11 has been cleaned andprepared (FIG. 1A), the injection port 10 is placed against a patient'sskin at a desired location, and the cannula 14 is inserted into thesubcutaneous tissue (FIGS. 1D, 1E and 1F). The cannula 14 is preferablyinserted by an automatic insertion device 18 (FIGS. 1B and 1C), such asthose available from Unomedical a/s of Birkeroed, Denmark. Suitableinsertion device are disclosed in U.S. Pat. Nos. 6,830,562 to Mogensenet al. and 7,115,112 to Mogensen et al., both of which are herebyincorporated by reference in their entirety.

With the injection port in place, a therapeutic substance, such asinsulin, may be injected through the injection port by utilizing aconventional syringe 20 (FIG. 1G), a conventional pen needle injectiondevice (not illustrated), or the like. Suitable syringes are availablefrom the assignee of the present application, Becton, Dickinson andCompany of Franklin Lakes, New Jersey. To inject the therapeuticsubstance, the cannula of the syringe or pen needle is placed throughthe septum 16 of the injection port 10, and the therapeutic substance isdischarged.

To facilitate the use of a conventional syringe with the injection portand to prevent misalignment of the cannula with the injection port,adapters that interface the syringe with the injection port may beprovided. Exemplary embodiments of suitable adapters will now bedescribed, and additional details of the injection port will bediscussed as necessary in connection with the detailed description ofthe adapters.

FIGS. 2-5 illustrate an injection port adapter 100 according to anexemplary embodiment of the present invention. The injection portadapter 100 provides an interface between a conventional, commerciallyavailable syringe and an injection port. The injection port adapter 100has a hollow body 102 with a first end 104 and a second end 106. Thefirst end 104 of the hollow body 102 receives the end of the syringe 20and guides the syringe 20 into a desired position within the hollow body102. The second end 106 of the hollow body 102 has a geometricconfiguration that corresponds to a corresponding mating portion of theinjection port. In this manner, as will be discussed in further detailbelow, the cannula 22 of the syringe 20 is guided to and held at theappropriate location with respect to the injection port.

In the illustrated embodiment, the first end 104 of the hollow body 102is an annular, ring-shaped member 108. The inner diameter of the annularring 108 is large enough to allow the end of the syringe to pass throughand enter into the adapter.

The annular ring 108 is connected to the second end 106 of the adapter100 by a plurality of ribs 110. In the illustrated embodiment, threeribs 110 are used to connect the annular ring to the second end 106 ofthe adapter 100. Any number of ribs may be used, however. A solidconnection may also be used to form the connection. The use of ribs,however, minimizes the surface area of the adapter 100, and thereforeminimizes the potential of the cannula 22 of the syringe 20 coming intocontact with the adapter 100. Contact between the needle and anon-sterile adapter has the potential to introduce foreign bodies intothe body and contaminate the needle.

A centering ring 112 is disposed in the hollow body 102, and issupported by the plurality of ribs 110. The centering ring 112 receivesthe end of the syringe, and holds the end of the syringe in a stableposition. Preferably, the inner diameter of the centering ring forms afriction fit with the end of the syringe to hold the adapter in place onthe end of the syringe. Moreover, a syringe typically has a hub 24 withan annular flange 26 near the end of the syringe so that a sterility cap28 may be placed on the end of the syringe (see FIG. 6). As seen in FIG.5, when the adapter 100 is placed on the syringe 20, the annular flange26 on the syringe 20 is pressed against the centering ring 112.Consequently, the centering ring 112 both aligns the syringe 112 withthe adapter and controls the depth of the insertion of the cannula 22.

The adapter 100 may be formed of any suitable material, such aspolypropylene. The adapter 100 may be formed by any conventionalmanufacturing method, including injection molding and the like.

To use the adapter 100 to make an injection of a therapeutic substancethrough an injection port, a user removes the sterility cap 28 from asyringe 20. The syringe 20 may be pre-loaded with a therapeuticsubstance. More typically, however, a user will load the syringe 20 witha dose of a therapeutic substance contained in a separate container,such as a vial, in a conventional manner. The user may then move the endof the loaded syringe 20 through the annular ring 108 of the adapter 100and into the centering ring 112 until the annular flange 26 of thesyringe 20 abuts the centering ring 112. The syringe 20 and adapter arenow ready for use. At this point, it should be noted that the cannula isrecessed within the adapter so that accidental punctures are minimized.

The syringe 20 and the attached adapter 100 are then brought to theinjection port 10. As seen in FIG. 7, the injection port 10 has a matingportion 30 for engaging the second end 106 of the injection port adapter100. In the illustrated exemplary embodiment, the mating portion 30 isan annular recess. The second end 106 of the injection port adapter 100is placed into the mating portion 30 and engages the mating portion 30so that the injection port adapter 100 is held in a stable manner.Although the second end 106 of the adapter 100 and the correspondingmating portion 30 are annular in the illustrated exemplary embodiment,other shapes may be used if desired.

When the injection port adapter 100 is placed into the mating portion onthe injection port 10, the cannula 22 pierces the septum 16 of theinjection port 10, and the engagement of the mating portion 30 and thesecond end 106 of the adapter 100 assures that the cannula 22 is placedat the proper depth within the injection port. After the syringe hasbeen placed on the injection port, the syringe may be used to dispensethe therapeutic substance contained in the syringe into the injectionport. The therapeutic substance then travels through the soft cannula 14of the injection port 10 and into the subcutaneous tissue.

At this point, the syringe 10 and adapter 100 assembly may be removedfrom the injection port. Typically, the syringe 10 will be disposed offor safety and health reasons. The adapter 100 may also be disposed of.The adapter 100, however, does not directly contact any body fluids, andmay be reused if desired.

FIGS. 8-11 show a syringe 20 and an injection port adapter 200 inaccordance with another exemplary embodiment of the present invention.The injection port adapter 200 of this exemplary embodiment includes ahollow body 202 with a first end 206 and a second end 204. The hollowbody 202 has a first body portion 208 and a second body portion 210. Thefirst body portion has a first attachment collar portion 212 and a firstfoldable portion 214 that is pivotable with respect to the firstattachment collar portion 212. The foldable portions may be pivotablyattached by a living hinge or other conventional pivotable connection.The second body portion 210 has a second attachment collar portion 216and a second foldable portion 218 that is pivotable with respect to thesecond attachment collar portion 216.

The injection port adapter 200 may be formed of any suitable material,such as polypropylene. The adapter may be formed by any conventionalmanufacturing method, including injection molding and the like.

To utilize the injection port adapter 200 of this exemplary embodimentof the invention, the first and second body portions 208, 210 areassembled together so that the first and second attachment collarportions 212, 216 form an attachment collar 220 surrounding the barrel32 of the syringe 20. Preferably, the pieces have conventional snapfasteners so that they may be snapped together. Other suitable fasteningmethods known to those skilled in the art can also be used. Thisassembly may be done by the end user of the device. During the assemblyprocess so far, the sterility cap 28 of the syringe 20 does not need tobe removed, thereby minimizing potential contamination of the cannula22.

Once the first and second body portions 208, 210 have been assembledtogether, the sterility cap 28 may be removed from the syringe 20, asshown in FIG. 9. Next, the first and second body portions 208, 210 maybe slid towards the end of the syringe. The first and second bodyportions 208, 210 have recesses 222 for accommodating the annular flange26 on the hub 24 of the syringe 20. At this time, one of the foldableportions 214 or 216 is placed at the proper location on the syringe 20so that the annular flange 26 is disposed in the corresponding recess222 of the foldable portion. The other foldable portion 214 or 216 isthen folded together to close the portions around the syringe 20 andform the adapter. A fastener, such as a snap style fastener using pins226 that extend through corresponding apertures 228, may be provided tohold the foldable portions closed with respect to one another.

The syringe 20 and the injection port adapter 200 may now be used toinject a therapeutic substance through an injection port. It should benoted that once the adapter has been placed on the syringe, it may bedifficult or even impossible to load the syringe 20 using a vial becausethe cannula 22 is shrouded by the injection port adapter 200. Therefore,the syringe may be loaded prior to sliding the first and second bodyportions 208, 210 towards the end of the syringe, as mentioned above.Alternatively, a vial adapter (see FIGS. 38-42) may be provided tofacilitate loading the syringe from a vial. Further details regardingsuch an adapter will be discussed below.

FIGS. 12-15 show a syringe 20 and an injection port adapter 300 inaccordance with another exemplary embodiment of the present invention.The injection port adapter 300 of this exemplary embodiment includes ahollow body 302 with a first end 306 and a second end 304. The first end306 of the hollow body has an opening 308 for receiving the end of thesyringe 20. As seen in FIG. 15, the syringe 20 may have a hub portion 24as previously discussed, and the first end 306 of the hollow body 302may mate with the hub portion 24 of the syringe 20. The second end 304of the hollow body 302 has a geometric configuration that engages themating portion of the injection port.

A cap 310 is provided to cover the second end 304 of the adapter 300.The cap 310 preferably seals tightly with the second end 306 of theinjection port adapter 300 so that the sterility of the cannula of thesyringe 20 is maintained. Thus, the injection port adapter 300 and theassociated cap 310 may be used to replace a conventional sterility cap.That is, the adapter 300 may serve as both a sterility cap and anintegrated adapter.

The adapter may be formed of any suitable material, such aspolypropylene. The adapter may be formed by any conventionalmanufacturing method, including injection molding and the like.

Typically, the injection port adapter 300 of this exemplary embodimentof the invention is delivered to an end user already installed on thesyringe 20. To use the adapter 300, a user removes the sterility cap 310to expose the end of the adapter 300. If the syringe 20 is notpre-loaded, the user then loads the syringe 20 with a dose of atherapeutic substance. This may be done using a vial adapter, which isdiscussed below. The loaded syringe 20 and the attached adapter 300 arethen brought to the injection port, the second end 304 of the adapter300 is brought into engagement with the mating portion of the injectionport 10, and the injection is made. After the injection, the syringe andthe associated adapter will typically be disposed of for health andsafety reasons.

FIGS. 16-21 show a syringe and an injection port adapter 400 inaccordance with another exemplary embodiment of the present invention.The injection port adapter 400 of this exemplary embodiment includes ahollow body 402 with a first end 406 and a second end 404. The hollowbody 402 has a first body portion 408 and a second body portion 410. Thefirst and second body portions are pivotable with respect to oneanother, preferably by a living hinge.

The first body portion 408 has a first attachment collar portion 412 anda first foldable portion 414 that is pivotable with respect to the firstattachment collar portion 412. Preferably, the first and second bodyportions are connected by a living hinge. The second body portion 410has a second attachment collar portion 416 and a second foldable portion418 that is pivotable with respect to the second attachment collarportion 416.

The adapter 400 of this exemplary embodiment of the invention ispreferably formed in a flattened state, as shown in FIG. 16, byinjection molding or the like. To install the adapter 400 on a syringe20, the flattened adapter is placed adjacent to the syringe. The firstand second attachment collar portions 412, 416 have recesses 422 foraccommodating the annular flange 26 on the hub 24 of the syringe 20.These recesses 422 are aligned with the annular flange 26 on the hub 24of the syringe 20, and the first and second body portions 408, 410 arefolded together so that the first and second attachment collar portions412, 416 form an attachment collar 420 around the hub 24 of the syringe20, as shown in FIG. 21. Preferably, the pieces have conventional snapfasteners so that they may be snapped together. Other suitable fasteningmethods known to those skilled in the art can also be used. During thisassembly process, the area where the adapter 400 contacts the syringe 20extends back and away from the cannula, thereby minimizing the potentialof contamination. At this time, the cannula 22 of the syringe 20 isexposed, and the syringe 20 may be loaded with a therapeutic substancefrom a vial.

After the syringe is loaded, the first and second foldable portions 414,418 are folded back to form the hollow body 402 of the adapter 400, asshown in FIG. 19. Preferably, the pieces have conventional snapfasteners so that they may be snapped together. Other suitable fasteningmethods known to those skilled in the art can also be used. With thisconfiguration, the cannula 22 is shrouded and recessed for safety.Preferably, the injection port adapter 400 is assembled to the syringe20 by the end user of the device.

The syringe 20 and the injection port adapter 400 may now be used toinject a therapeutic substance through an injection port. The process issubstantially the same as discussed above, and thus will not berepeated.

FIGS. 22-26 show a syringe 20 and an injection port adapter 500 inaccordance with another exemplary embodiment of the present invention.The injection port adapter 500 of this exemplary embodiment includes ahollow body 502 with a first end 504 and a second end 506. The hollowbody 502 is a unitary, one-piece adapter. A slit 508 is formed along oneside of the hollow body. The slit 508 allows the hollow body 502 to flexso that a syringe 20 may be passed through the slit 508 so that the body502 accommodates the syringe 20.

To use the adapter 500, a user places the adapter on a syringe 20 bypressing the syringe 20 through the slit 508 in the body of the adapter.Preferably, the adapter 500 is loaded on the middle portion of thesyringe (that is, the position shown in FIGS. 22 and 23). After theadapter is in place, the user may remove the sterility cap from thesyringe 20 and load the syringe with a therapeutic substance. Since theadapter is located away from the end of the syringe, it does notinterfere with the dosing of the syringe. Once the syringe has beenloaded, the user slides the adapter 500 down the barrel of the syringe20 until the hub 24 engages the body of the adapter, as shown in FIG.25. The adapter is now in the proper position for use. To assure thatthe adapter 500 does not slide back up the barrel of the syringe, theadapter may include locking features, such as a locking tab 510, toengage the hub 24 of the syringe 20.

Once the therapeutic substance has been removed, the adapter 500 may beremoved from the syringe by squeezing the tip of the adapter, whichcauses enough deformation to disengage the locking features of theadapter 500 from the syringe. To facilitate removal, gripping features,such as wings, may be provided on the adapter. Once removed, the adapter500 may be reused or it may be discarded.

In the above descriptions, the exemplary embodiments of the injectionport adapters have been described in connection with a conventional,syringe style injection device. The injection port adapters are notlimited to syringe style injection devices, however, and may be usedwith alternative injection devices, such as pen style injection systems.One such pen style injection system is described in U.S. Pat. No.5,941,857, which is hereby incorporated by reference in its entirety.

FIGS. 27-31 show a pen needle with an integrated injection port adapter600 which is suitable for use with a pen needle delivery systemaccording to an exemplary embodiment of the present invention. Theadapter 600 has an outer shield 602, a sterility cap 608, a pen needleassembly 610 (which may be, for example, a 12.5 mm assembly), and a foilor paper sterility barrier 612. The outer shield 602 has a first end 604and a second end 606. The sterility cap 608 has, for example, threeannular rings 614 similar to those used in a syringe sterility cap andis placed over the second end of the outer shield to form a sterilebarrier. The foil or paper sterility barrier 612 is placed over theopening in the first end 604 of the outer shield 602 to maintain asterile environment within the pen needle. The opening of the first end604 of the outer shield 602 is configured to mate with a pen deliverysystem, such as with threads.

To use the adapter 600, the foil or paper sterility barrier 612 ispeeled off, and the outer shield 602 is attached to a delivery pen, suchas by screwing it onto the delivery pen. The sterility cap 608 isremoved from the second end 606 of the outer shield 602 to expose theshielded needle assembly 610. The second end 606 of the outer shield 602has a geometry that mates with the mating portion 30 of the injectionport 10, as discussed above. Thus, the adapter 600 assures that theneedle is properly aligned with the septum of the injection port 10 andthat the needle is not inserted too far into the injection port. Oncethe therapeutic substance has been delivered through the injection port10, the adapter may be removed from the delivery pen and discarded.Before removal, the sterility cap 608 may be placed back onto theadapter 600. Because the needle is covered, however, it is safe todispose the pen needle and shield assembly without replacing thesterility cap 608.

FIGS. 32-34 show a pen needle with an integrated injection port adapter700 which is suitable for use with a pen needle delivery systemaccording to another exemplary embodiment of the present invention. Withthe exception of the sterility cap 708, this embodiment of the inventionis substantially identical to the just described embodiment. In thisembodiment, the sterility cap 708 of the invention has a pair of outerwings 710 which may be used as an aid to remove the cap. Further, inthis embodiment, the sterility cap 708 is preferably welded to theadapter 700 using an energy director ring 712 and ultrasonic or spinwelding. This creates an air tight seal that is broken by a user whenthe cap 708 is twisted off.

FIGS. 35-37 show an adapter 800 for using a conventional pen needleassembly with an injection port 10 according to another exemplaryembodiment of the present invention. The adapter 800 has first, second,and third legs 802, 804, and 806 that are connected together to form atriangular shaped body 809. The first and second legs of the adapterhave first and second recesses 808, 810, respectively, that accommodatea pen needle assembly. The first and second legs of the hollow body alsohave extending struts 812 that are arranged in a geometric pattern thatcorresponds to the shape of the mating portion of an injection port whenthe adapter 800 is folded. In this manner, the struts 812 engage themating portion 30 of the injection port 10 to accurately position theneedle of the pen needle assembly.

Preferably, the adapter is formed in a flat pattern to minimizepackaging space. To do so, the first and second legs may be connected bya living hinge 814, and the second and third legs may be connected byanother living hinge 814. The ends of the first and third legs have aslot 816 and complementary tab 818. With this configuration, a user mayfold the three legs into a triangular shape and fasten the legstogether. The adapter may be formed of any suitable material, such aspolypropylene. The adapter may be formed by any conventionalmanufacturing method, including injection molding and the like.

As mentioned above, with certain exemplary embodiments of the presentinvention, it may be difficult or even impossible to load a syringe froma vial once the adapter is placed onto the syringe. To overcome thisdifficulty, an adapter 900 for a vial may be provided. An exemplaryembodiment of such an adapter 900 is shown in FIGS. 38-42. The adapter900 has a disc portion 902 with a bottom surface 904 and a top surface906. A plurality of flexible fingers 908 extend downward from the bottomsurface. The flexible fingers 908 have a retention flange 910 formed onan inner surface. The flexible fingers 908 are positioned so that theyaccommodate the neck of a vial, and the flexibility of the flexiblefingers 908 allow the retention flange 910 to pass over the crimp ringon the neck of a vial and hold the adapter in place. Furthermore, theflexibility of the flexible fingers 908 allows the vial adapter 900 tobe used with a range of vial sizes.

A cylinder 912 extends from the top surface 906 of the disc 902. Thecylinder 912 has an outside diameter that corresponds to the innerdiameter of the above-described insulin port adapters. A septum 914covers the opening at the top of the cylinder 912 to form a hollowcavity 916 within the cylinder 912. Preferably, the septum 914 is flushwith the top edge of the cylinder to facilitate wiping the septum withan alcohol swab between uses. A cannula 918 extends through the disc 907into the hollow cavity 916.

The first step in using the vial adapter is to place the vial adapter900 on the vial. To do so, the flexible fingers 908 are placed over theneck and crimp ring of a vial of a therapeutic substance, and the vialadapter 900 is pressed down. The flexible fingers 908 flex outward topass over the crimp ring. As the vial adapter 900 is pressed furtherdown, the retention flange 910 on the inner surface of the flexiblefingers 908 passes the crimp ring, and the flexible fingers 908 returnto their original position so that the vial adapter is held onto thevial. Meanwhile, the cannula 918 of the vial adapter 900 is pressedthrough a septum on the top of the vial, thereby forming a passagebetween the interior of the vial and the hollow cavity 916 on the vialadapter 900.

Once the vial adapter 900 has been placed on the vial, as shown in FIG.41, a syringe 20 with an injection port adapter may be placed over thetop cylinder 912 of the vial adapter, as shown in FIG. 42. The cannulaof the syringe 20 punctures the septum 914 at the top of the vialadapter 900 and enters the cavity 916 in the vial adapter. The vial,vial adapter, and syringe are all inverted, and the syringe is operatedto load the therapeutic substance into the syringe. Once the syringe isloaded, the syringe may be removed and used with an injection port inthe manner described above. The vial adapter may be removed from thevial, or may be left in place for future use.

The vial adapter 900 may be formed of any suitable material, such aspolypropylene. The adapter may be formed by any conventionalmanufacturing method, including injection molding and the like.

It should be understood that although the exemplary embodiment of thevial adapter has a cylinder for mating with an injection port adapter,the vial adapter is not limited to a cylindrical shape. Any geometricpattern that mates with the injection port adapter of a syringe ispossible.

While the invention has been shown and described with reference tocertain embodiments thereof, it will be understood by those skilled inthe art that various changes in form and details may be made thereinwithout departing from the spirit and scope of the invention as definedby the appended claims and their equivalents. For example, although asubcutaneous injection port has been described herein, the principles ofthe present invention are applicable to other types of injection ports,such as intradermal injection ports.

What is claimed is:
 1. An adapter for utilizing a pen delivery systemwith an injection port, comprising: an outer shield having a first endand a second end, the first end of the outer shield being configured tomate with a pen delivery system, the second end of the outer shieldbeing configured to mate with an injection port; and a pen needlefixedly disposed in the outer shield
 2. An adapter according to claim 1,further comprising a sterility cap adapted to be placed over the secondend of the outer shield to form a sterile barrier.
 3. An adapteraccording to claim 2, wherein the sterility cap is welded to the outershield.
 4. An adapter according to claim 2, wherein a plurality oflongitudinally extending ribs are disposed on the sterility cap tofacilitate removal of the sterility cap from the adapter.
 5. An adapteraccording to claim 2, wherein a plurality of wings are disposed on thesterility cap to facilitate removal of the sterility cap from theadapter.
 6. An adapter according to claim 2, wherein a removableprotective barrier is disposed at the first end of the outer shield, theremovable protective barrier being removed prior to engagement with thepen delivery system.
 7. An adapter according to claim 6, wherein theremovable protective barrier is a paper or foil sterility barrier.
 8. Anadapter according to claim 1, wherein a plurality of annular rings aredisposed on an inner surface of the sterility cap to provide a sterilebarrier.
 9. A vial adapter for use with an injection port adapter,comprising: a disc with a bottom surface and a top surface; a pluralityof flexible fingers extending from the bottom surface of the disc, theplurality of flexible fingers having a circumferentially extendingretention flange formed on an inner surface of the fingers, wherein theflexible fingers are configured to fit over a neck of a vial, and theflexible fingers allow the retention flange to pass over a crimp ring onthe neck of the vial; a cylinder extending from the top surface of thedisc, the cylinder having an outside diameter that corresponds to theinner diameter of an injection port adapter; a septum covering anopening at the top of the cylinder to form a cavity within the cylinder;and a cannula that extends through the disc into the cavity in thecylinder.
 10. A vial adapter according to claim 9, wherein the septum isflush with a free end of the cylinder.